BEUDAMED
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    FOOTHILLS SURGICAL DRAPES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780767·LEVAMED ACTIVE ANKLE SUP SLVR L IV

    TASMIN R 4°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844014424·The basic shape of the TASMIN R devices is a ho...

    CHLORAPREP ONE-STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code KXF·August 31, 2020

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve

    Entuit Thrive

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002356207·Entuit Gastrostomy BR Balloon Retention Feeding...

    RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/80MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·April 2, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 8, 2013

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·May 8, 2008

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 6, 2011

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018